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ISRCTN
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ISRCTN12357672
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of the effectiveness of a paediatric head injury co-ordinator nurse in reducing subsequent contact with health care professionals
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0544139664
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Study hypothesis
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Approximately 15-20% of so called 'mild' head injured children develop morbidities that necessitate further healthcare interventions. 1000 children are seen in Accident and Emergency (A&E) at Addenbrooke's with 'mild head injury' per year. Our study will be conducted in two parts.
On discharge from the accident and emergency department following a minor head injury, the carers of children are given an information card containing information on expected side effects from the accident. This card is standard care and a requirement following NICE (National Institute of Clinical Excellence) guidelines.
Stage 1: A population-based observational study in order to calculate a sample size for stage 2. Following informed consent, we will contact families 2 weeks following their child's A&E attendance and ask a series of questions around their child's recovery to ascertain how long their child had off school and if the family had to seek further help or advice from the GP or A&E department. This stage of the work will be used as a pilot study and the results obtained will allow us to calculate the sample size needed for stage 2, a randomised controlled trial. The information card will be adapted to include the following name and contact number 'Deborah White, Paediatric Research Nurse - 01223 245151 bleep 151-879'.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Not Applicable: Service delivery
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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04/03/2003
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Anticipated end date
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03/03/2007
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Following informed consent, families will be randomised to one of two groups.
The first group will be contacted 1 week following injury to ascertain the progress of the child and offer advice to the family about dealing with the expected symptoms following a head injury.
Both groups 1 and 2 will be contacted 2 weeks following the injury as in stage 1.
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Primary outcome measure(s)
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The two groups would then be compared to see if the number of visits to A&E or to the GP were any different across the two groups.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cambridge Consortium - Addenbrooke's (UK)
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Trial website
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Publications
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Contact name
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Mrs
Deborah
White
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Address
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Box No 7
Paediatric Intensive Care Unit
Addenbrooke's NHS Trust
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)1223 217613
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Email
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deborah.white@addenbrookes.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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30/03/2011
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Date ISRCTN assigned
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30/09/2004
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